(77 days)
Not Found
No
The document describes a laser handpiece and its intended uses, focusing on its physical characteristics and performance studies related to skin resurfacing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for medical treatments such as skin resurfacing, treatment of wrinkles, and removal of various skin lesions (e.g., epidermal nevi, spider veins, warts, skin tags), which are therapeutic interventions.
No
The device is described as a laser handpiece indicated for soft tissue resurfacing and treatment of various skin conditions, which are therapeutic applications, not diagnostic ones.
No
The device is a laser handpiece, which is a hardware component that emits laser energy for medical procedures. It is described as working in conjunction with other hardware platforms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- This device is a laser handpiece used for direct treatment of soft tissue (skin and cutaneous tissue) on the patient's body. Its intended uses are therapeutic procedures like skin resurfacing, wrinkle treatment, and removal of various skin lesions.
The description clearly indicates a device used for treatment, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
With microbeam end piece it is indicated for Skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece.
2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece.
Its emission is triggered by means of a footswitch connected to the console of the device it is used with.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin and cutaneous tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are provided in support of the substantial equivalence determination, for the Er:YAG handpiece used in conjunction with the devices it is intended to be used with.
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Quanta Forte device.
The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
The Er:YAG handpiece does not contain any software, as it is controlled by the software of the devices it is used in conjunction with (already FDA cleared). Those software were not modified due to the use with the microbeam Er:YAG handpiece.
They successfully underwent verification and validation testing and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.
Biocompatibility:
The biocompatibility of the Er:YAG handpiece is established based on the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2017
Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs and Quality Assurance Via Acquedotto, 109 Samarate, IT 21017 VA
Re: K173002
Trade/Device Name: 2940 nm Er: Yag Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 18, 2017 Received: September 27, 2017
Dear Francesco Dell'antonio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -53
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173002
Device Name 2940 nm Er: Yag Laser Handpiece
2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as,
but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi;
Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
With microbeam end piece it is indicated for Skin resurfacing.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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5. 510(K) SUMMARY
Introduction:
This document contains the 510(k) Summary for the 2940 nm Er:YAG handpiece. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant / Manufacturer Name and Address: | Quanta System SPA
Via Acquedotto, 109
Samarate (VA)
Italy 21017 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
V.P. Regulatory Affairs and Quality Assurance
Quanta System S.p.A.
Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | 12/11/2017 |
| Device Name: | 2940 nm Er:YAG laser handpiece |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery
and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
Predicate Devices:
The modified device 2940nm Er:YAG handpiece is derived from the legally marketed (unmodified) device 2940nm handpiece cleared under Quanta Forte platform (K152714).
2940nm Er:YAG handpiece is substantially equivalent to the following legally marketed predicate devices:
- Primary predicate: K152714 Quanta Forte - QUANTA SYSTEM SPA Additional predicate:
- K132806 FOTONA F-22 LASER HANDPIECE, FOTONA FS-01 LASER HANDPIECE - FOTONA D.D.
- . K152153 MicroSpot Handpiece - ASCLEPION LASER TECHNOLOGIES GMBH
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Performance Standards:
There are no mandatory performance standards for this device.
Description of the device:
2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece.
2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece.
lts emission is triggered by means of a footswitch connected to the console of the device it is used with.
Intended use
2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
With microbeam end piece it is indicated for Skin resurfacing.
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Summary of technological similarities and differences of the new device in comparison with the predicate
| Specifications | Subjected device | Original
(unmodified
device) | additional predicate device | |
|---------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/
Device Name | 2940 nm Er:YAG
Laser Handpiece | Quanta Forte | Fotona F-22/FS-
01 Laser
Handpiece (F-
RUNNER) | MicroSpot
Handpiece |
| 510(K) # | - | K152714 | K132806 | K152153 |
| Submitter | Quanta System
S.p.A. | Quanta System
S.p.A. | FOTONA D.D. | Asclepion Laser
Technologies GmbH |
| Laser medium | Er:YAG | Er:YAG | Er:YAG | Er:YAG |
| Wavelength
[nm] | 2940 | 2940 | 2940 | 2940 |
| Energy, max
[J] | 3 | 3 | 3 | 2.5 |
| Fluence
[J/cm²] | Up to 95 (non
microbeam mode);
Up to 121 (with
stacking pulses –
microbeam mode) | Up to 95 (non
microbeam
mode); | Up to 300
(stacking pulses
– microbeam
mode) | Up to 51 (stacking
pulses - microbeam
mode with 600 µm
dots)
Up to 150
(stacking pulses –
microbeam mode
with 300 µm dots) |
| Pulse duration
[ms] | 0.3 to 1.5 ms | 1 to 1.5 ms | 0.1 to 1.5 ms | 0.1 -1.0 ms |
| Repetition rate,
max
[Hz] | 6 | 5 | 50 | 20 |
| Spot size | Ø 2, 4, 9mm
Ø 9mm dots array | Ø 2, 4, 9mm | 13x13 mm dots
array | 13x13 mm dots
array |
Performance data:
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The following performance data are provided in support of the substantial equivalence determination, for the Er:YAG handpiece used in conjunction with the devices it is intended to be used with.
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Quanta Forte device.
The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
The Er:YAG handpiece does not contain any software, as it is controlled by the software of the devices it is used in conjunction with (already FDA cleared). Those software were not modified due to the use with the microbeam Er:YAG handpiece.
They successfully underwent verification and validation testing and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.
Biocompatibility:
The biocompatibility of the Er:YAG handpiece is established based on the predicate devices.
Conclusion:
The subject device is comparable to its primary predicate and the additional predicate devices as it has similar intended use and core fundamental technology as show in the SE table above.
Therefore, Er:YAG handpiece is substantially equivalent to its identified predicate devices.